FDA Recall Terminated

Disposable Oxygen Mask & Bag, Adult Non-Rebreathing Mask w/Safety Vent and 84'' Tube; reorder no. 7022; SIngle Patient Only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

Recall: Z-1127-04 · Initiated July 12, 2004

Recall

Recall Number: Z-1127-04
Event Number: 29496
Firm: Medex Inc
FEI Number: 1526863
Product Code: KGB
Status: Terminated
Root Cause: Other
Initiated: July 12, 2004
Posted: July 22, 2004
Terminated: February 7, 2005
Address: 6250 Shier Rings Rd, Dublin, OH, 43016-1270

Description

Reason

The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.

Action

Medex telephoned the direct accounts on 7/12/04, and will fax and mail follow-up recall letters dated 7/2/04 on 7/13/04, informing them that the affected products were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containing latex. The accounts were requested to cease distribution/use of the affected lots and return them to Medex for free replacement. The accounts were asked to contact Customer Service at 1-800-848-1757 to make arrangements for the return and replacement of their affected product. Distributors were requested to sub-recall the products from their customers. Any questions were directed to Terri Davis at 1-800-848-1757, ext. 5542.

Distribution

California, Colorado, Connecticutt, Florida, Georgia, Illinois, Indiana, Kansas, New Jersey, New York, Tennessee and Texas.

Quantity

302 units